Lung Cancer Mutation Consortium Protocol

Brief Title

Lung Cancer Mutation Consortium Protocol

Official Title

Lung Cancer Mutation Consortium Protocol

Brief Summary

      The primary objective of this protocol is to determine the frequency of oncogenic mutations
      in 1000 patients with advanced adenocarcinoma of the lung. The linked clinical and mutational
      analyses will be used to determine the frequency of each mutation, its association with
      clinical features and outcome, and its association with other mutations. As future
      therapeutic protocols specific for these mutations are developed, patients may be notified of
      their eligibility for these studies. Future translational studies may be used to: a) unravel
      the complex biology of lung cancer; b) identify prognostic markers; c) define predictive
      markers of response/resistance to new therapies; d) identify new targets. A secondary goal is
      to establish a consortium of sites that have the capability of conducting multiple mutation
      testing in a Clinical Laboratory Improvement Amendments (CLIA) certified lab.
    

Study Type

Observational

Primary Outcome

Frequency of oncogenic mutations in patients with advanced adenocarcinoma of the lung.

Secondary Outcome

 Associations between each mutation and clinical outcomes.

Condition

Adenocarcinoma of Lung, Stage IV

Study Arms / Comparison Groups

 Advanced Adenocarcinoma

Description:  Stage IV adenocarcinoma who have undergone biopsy with remnant tissue.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Estimated Enrollment

1100

Start Date

September 16, 2009

Completion Date

September 30, 2024

Primary Completion Date

September 1, 2016

Eligibility Criteria

        Inclusion Criteria:

          1. Subjects (=> 18 years of age) who are undergoing further evaluation for the diagnosis
             or treatment of advanced adenocarcinoma of the lung.

          2. Diagnosed May 2012 or later

          3. Oral and written informed consent.

        Exclusion Criteria:

          1. Lung cancer histologies other than adenocarcinoma

          2. Lack of adequate tissue.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Paul Bunn, M.D., , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT01014286

Organization ID

09-0756.cc

Responsible Party

Sponsor

Study Sponsor

University of Colorado, Denver

Study Sponsor

Paul Bunn, M.D., Study Director, University of Colorado, Denver

Verification Date

January 2023